By Jonathan Lee, VP of Development Operations; and Deborah Bisio Dwyer, Leader of Outsourcing Group, Cerexa
In this day and age of preferred service provider relationships and/or functional service providers, small pharmaceutical and biotechnology companies present a unique challenge to service providers vying for their business. The resource constraints (both money and people) and timelines are critical, given a narrow or single product development pipeline, little to no revenue stream, and a hyperfocused management team. While these issues may not be unique to small companies, oftentimes the viability of a project, and possibly the company, may lie within two critical aspects — the people and on-time delivery of the project.
By Claudia M. Huether and Dr. Falk Schneider, DASGIP AG, Jülich
The pharmaceutical industry and regulatory authorities are facing new challenges in the development of new drugs that have complex interdependencies. The following provides some insights into the more notable advantages of using process-integrated data management in tandem with parallel bioreactor systems.